Job Overview

Assist with the overall Safety system implementation, support, configuration, and migration related activities. Responsible for providing this service to clients either as a support function to the client project groups or as stand- alone business. Responsible for providing all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.

Summary Of Responsibilities

PV systems expert responsible for leveraging a strong combination of business and technical knowledge.
Conduct project specific configurations in Safety systems.
Maintain and document system configuration based on initial requirements and any subsequent changes.
Evaluate proposed project ideas /software changes through technical impact analysis and estimated business value to contribute to decision-making.
Develop and document standard and ad hoc reports from the safety systems.
Support and educate end users and sponsors, if applicable.
Collaborate with training team in development of safety system specific training Module.
Initiate discussions with business stakeholders to understand business requirements, document user requirements and ensure requirements are delivered on time and in collaboration with Tech partner.
Provide overall guidance and strategize use of standard safety systems front-end reporting including use of advanced conditions and Standard MedDRA Queries (SMQ).
Conduct routine and ad hoc data extraction (i.e., PSURs, DSURs, 6-monthly listings).
Actively participate in all data migration activities and documentation related to migration.
Support with change management and training of the systems, as needed.
Expertise in Ticket management, issue resolution and escalating system issues where applicable.
Respond to mailbox queries.
Vendor management.
Train team members on technical and functional aspects.
Completing work assignments to the highest quality standards, adhering to relevant SOPs, and keeping up to date with knowledge of current PV regulations.
Making updates to Departmental Standard Operating Procedures, Working Practices and Guidelines.
Monitor the mailbox for system failures to resolve in a timely manner.
Subject matter expert, looking for ways to improve compliance, quality, and efficiency.
Perform User Acceptance Testing and complete required documentation.
Lead critical team projects, responsible for managing team's workload.
And all other duties as needed or assigned.

Qualifications (Minimum Required)

Life Science or IT/computing degree.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Good team player and offer peer support as needed.
Ability to set priorities and handle multiple tasks.
Attention to detail.
Good written and verbal communication skills.
Logical and spelling skills, preferably with an aptitude for handling and proof-reading numerical data.
Good keyboard skills, preferably with knowledge of MS office and Windows would be beneficial.
Ability to operate standard office equipment.

Experience (Minimum Required)

Experience in systems operations support role.
Experience working on any validated document management systems.
At least 4 years of experience with drug safety systems such as Argus/ARISg/Veeva.
Good working knowledge of Microsoft office tools.
System integration knowledge.

Preferred Qualifications Include

Clinical background working with clinical systems.
Good understanding of SQL programming language.
Experience working with ticket support applications.

Physical Demands/Work Environment

Office environment or remote.

Learn more about our EEO & Accommodations request here.

Lead Safety Systems Specialist